Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. Develop programs and utilities using various tools and languages to support ...
Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. Develop programs and utilities using various tools and languages to support ...
Senior Programmer, Clinical Data Evaluation
King Of Prussia, PA · Hybrid
$143K - $169K/yr
The incumbent applies strong expertise in CDASH and SDTM mapping, eCRF development, and EDC systems (e.g., Medidata Rave, Veeva Vault) to validate datasets, specifications, and vendor artifacts. The ...
Senior Programmer, Clinical Data Evaluation
King Of Prussia, PA · Hybrid
$143K - $169K/yr
The incumbent applies strong expertise in CDASH and SDTM mapping, eCRF development, and EDC systems (e.g., Medidata Rave, Veeva Vault) to validate datasets, specifications, and vendor artifacts. The ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site +1
$180K/yr
This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site +1
$180K/yr
This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Principal Statistical Programmer
$98.20K - $273.20K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
$98.20K - $273.20K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
... SDTM/ADaM), FDA eCTD; Tools: GitHub Projects, DevOps board, Jira, Power BI, Microsoft Fabric Understanding of Microsoft Fabric, governance policies, compliance documentation; exposure to BI solutions ...
... SDTM/ADaM), FDA eCTD; Tools: GitHub Projects, DevOps board, Jira, Power BI, Microsoft Fabric Understanding of Microsoft Fabric, governance policies, compliance documentation; exposure to BI solutions ...
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Associate Director/Director, Statistical Programming
South San Francisco, CA · On-site
$180K - $250K/yr
Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness * Develop, validate, and maintain CDISC-compliant datasets (SDTM ...
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is ...
Quick apply
Senior Manager, Statistical Programming - Job ID: 1646
Palo Alto, CA · On-site
$180K/yr
This position requires expertise in CDISC standards (SDTM, ADaM), strong communication and leadership skills, and a deep understanding of clinical trial data and analysis workflows. This position is ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
SDTM, ADaM, Define.xml, CDASH (with SEND awareness). * EDC Systems & Optimization : Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations ...
Responsibilities As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create ...
Responsibilities As a Statistical Programming Consultant, you will use your SAS and R programming skills to prepare SDTM and ADaM datasets, Tables, Listings, & Figures (TLFs), as well as create ...
Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. * Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and ...
Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. * Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and ...
... SDTM. • Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. • Develop programs and utilities using various tools and languages to ...
... SDTM. • Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration. • Develop programs and utilities using various tools and languages to ...
Director, Statistical Programming
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
New
Director, Statistical Programming
$235K - $248K/yr
Accountable for all core SP deliverables (SDTM, ADAM, TFLs) * May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks) * Provides ongoing data review by ...
New
Principal Programmer, Statistical Programming
San Diego, CA · On-site
$154.16K - $195K/yr
The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures. * Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions ...
New
Quick apply
Principal Programmer, Statistical Programming
San Diego, CA · On-site
$154.16K - $195K/yr
The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures. * Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions ...
New
Principal Statistical Programmer
Durham, NC · On-site
$98.20K - $273.20K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
Principal Statistical Programmer
Durham, NC · On-site
$98.20K - $273.20K/yr
SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...
... SDTM and ADaM datasets in accordance with CDISC standards Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions Validate program outputs and ...
... SDTM and ADaM datasets in accordance with CDISC standards Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions Validate program outputs and ...
Develop SDTM and ADaM datasets and supporting documentation.Prepare and review mapping specifications and annotated case report forms (CRFs).Perform quality control and validation activities for ...
Develop SDTM and ADaM datasets and supporting documentation.Prepare and review mapping specifications and annotated case report forms (CRFs).Perform quality control and validation activities for ...
Senior Statistical Programmer - Remote
Fairfield, CT · On-site +1
Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses Provide programming support to internal ...
Senior Statistical Programmer - Remote
Fairfield, CT · On-site +1
Provide statistical programming support to generate SDTM and ADaM data sets, tables, listings, and figures for individual studies as well as ISS/ISE analyses Provide programming support to internal ...
Sdtm information
See salary details
$19.23 - $24.78
4% of jobs
$24.78 - $30.33
9% of jobs
$30.33 - $35.88
4% of jobs
$35.88 - $41.43
7% of jobs
$41.78 is the 25th percentile. Wages below this are outliers.
$41.43 - $46.98
9% of jobs
The median wage is $52.53 / hr.
$46.98 - $52.53
17% of jobs
$52.53 - $58.09
7% of jobs
$58.09 - $63.64
14% of jobs
$65.40 is the 75th percentile. Wages above this are outliers.
$63.64 - $69.19
12% of jobs
$69.19 - $74.74
10% of jobs
$74.74 - $80.29
7% of jobs
$19
$54
$80
How much do sdtm jobs pay per hour?
What is an SDTM job?
What are the key skills and qualifications needed to thrive in the Sdtm position, and why are they important?
What are the typical daily responsibilities of an SDTM Programmer in a clinical research organization?

Principal Developer, Data Visualization and Application Development
BiogenCambridge, MA • On-site, Remote
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 25 days ago
Biogen rating
9.2
Based on 18 frontline employees who took The Breakroom Quiz
2nd of 70 rated pharmaceutical
Job description
Duties:
Create and maintain applications for required projects within the Data Visualization and Application Development team.
Responsible for creating and maintaining macros and programs used to create statistical programming deliverables, including SDTM.
Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration.
Develop programs and utilities using various tools and languages to support integration.
Maintain existing and develop new metadata tools to integrate across the systems in the study data flow and enable automation of SDTM including supporting overall Biogen efforts in streamlining data flow and data review.
Create and maintain programs to support and enhance under-represented population in Biogen's clinical trials.
Create and develop Dashboard for overall utilization and workload of functional service providers for better assessment and redistribution of tasks and ownership. Develop, project manage and maintain SharePoint site for functional groups.
Work on complex algorithms and coding to integrate all SDTM specifications and database specifications.
Build governance database to create a repository of all governance requests such that the governance requests and guidance can be tracked.
Create and provide training on "R" to SAS programmers.
Telecommuting permitted up to 20%.
Minimum Requirements:
Employer will accept a Bachelor's degree (or foreign equivalent) in Data Analytics, Information Systems, Information Technology or related field, and 4 years of experience in the job offered or in a Principal Developer, Data Visualization and Application Development-related occupation.
Position requires 24 months of experience in the following:
Working with CDISC data standards to ensure compliance and consistency of data analysis in clinical research.
Developing applications that facilitate data or components of a Clinical Study Report (CSR) intended for submission to a regulatory body.
Working within a GxP-compliant computing environment including knowledge of Good Clinical Practice (GCP) requirements for software.
Regulatory requirements for software used in clinical trials and submissions, including familiarity with FDA 21 CFR Part 11.
Position also requires 4 years of experience in the following:
Developing and optimizing R programs using packages including dplyr, data.table, and tidyr to efficiently extract, transform, and analyze large datasets, integrating results for advanced statistical modeling and visualization.
Creating dynamic visualizations including Plotly, ggplot2, RColorBrewer, and Leaflet to enhance data interpretation.
Generating and maintaining markdown validation reports using knitr.
Developing custom R functions using packages including purrr, dplyr, and stringr to enhance reusability, streamline workflows, and standardize analytical processes across projects.
Building data-driven applications with the R Shiny framework and automating reporting dashboards, ensuring seamless user interactivity and functionality.
Performing rigorous QC/QA validation checks using R packages and producing consolidated report outputs.
Upholding strong documentation practices, adhering to best coding standards in R, and managing version control with Azure DevOps or GitHub Repos.
Independently managing software projects and moving them to completion and demonstrating project management skills in a data/software environment.
Assessing data models and then applying them to existing data.
Working with relevant stakeholders to identify user requirements and working independently to create/optimize solutions.
Telecommuting permitted up to 20%.
Salary: $122,000 to $177,00/year
Hours: 9:00 a.m. to 5:00 p.m. Monday - Friday, approximately 40 hours/week.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
About Biogen
Sourced by ZipRecruiter
At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population.
Industry
Scientific research and development services
Company size
5,001 - 10,000 Employees
Headquarters location
Cambridge, MA, US
Year founded
1978